Brivekimig compared with placebo for moderate to severe hidradenitis suppurativa
Tests different doses of brivekimig in adults with moderate to severe hidradenitis suppurativa.
Key facts
- Who runs it
- Sanofi
- Where
- Atlanta, Baton Rouge, Chapel Hill, Dallas, Fort Myers, Johnston, Las Vegas, Miami, Miramar, Myrtle Beach, New York, Northridge, Phoenix, Savannah, Scottsdale, St Louis, and West Des Moines, United StatesSee the 17 sitesAlso in 18 other countries, 68 sites
- Trial code
- NCT07170917
- EU 2025-522333-61-00
- U1111-1318-3453
- Registry title
- Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 208 people, planned
- Started
- 6 Nov 2025
- Expected to end
- 23 Nov 2029
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Brivekimig
- Placebo
- Record updated
- 14 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate to severe hidradenitis suppurativa (HS), a long-lasting skin disease with painful lumps and abscesses. It tests brivekimig against placebo.
- Age
- 18 Years and older
- Sex
- All
- Disease stage
- Moderate to severe HS diagnosed at least 6 months before the start. Lesions in at least 2 separate body areas, one at Hurley Stage II or III. At least 5 abscesses and inflamed lumps (nodules), and 20 or fewer draining tunnels.
- Earlier treatment
- Oral antibiotics for HS did not work well enough, HS came back after stopping them, they were not tolerated, or they cannot be used. People who have had biologic drugs before, and people who have not, can join.
Main reasons for not taking part
- Other active skin disease or infection that may interfere with checking HS
- Recent or repeated serious infections, or a weakened immune system
- Past solid organ or stem cell transplant, or removal of the spleen
- Moderate to severe heart failure, or a disease that damages the nerve coating (demyelinating disease)
- Past cancer, except fully removed, non-spread squamous or basal cell skin cancer
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to Baseline
- Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III
- Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, demonstrated intolerance to antibiotics, or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history
- Participants must be either biologic-naive or biologic-experienced
- Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline visit
- Participant must have a draining tunnel count of ≤20 at the Baseline visit
Who cannot take part
- History (within last 2 years prior to Baseline visit) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator; The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial
- Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS
- History of recurrent or recent serious infection
- Known history of significant immunosuppression
- History of solid organ transplant or stem cell transplant
- History of splenectomy
- History of moderate to severe congestive heart failure
- History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
- Participants with a history of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured
- History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- A history of an Adverse Event (AE) attributed to or related to anti-TNF therapy (examples include, but are not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate readministration of an anti-TNF class therapy
- Participants are excluded from the study if any of the following criteria apply:
- Active suicidality and therefore significant suicide risk, as judged by the Investigator
Where in United States
Also in 18 other countries, 68 sites
- Advanced Medical Research - Atlanta- Site Number : 8400011Atlanta, United StatesTaking people
- Baton Rouge, LouisianaHospital not named in the registryTaking people
- University of North Carolina at Chapel Hill- Site Number : 8400025Chapel Hill, United StatesTaking people
- Ut Southwestern Medical Center, Department Of Dermatology- Site Number : 8400022Dallas, United StatesTaking people
- Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8400001Fort Myers, United StatesTaking people
- Clinical Partners- Site Number : 8400002Johnston, United StatesTaking people
- Las Vegas, NevadaHospital not named in the registryTaking people
- FXM Clinical Research - Miami- Site Number : 8400017Miami, United StatesTaking people
- FXM Clinical Research - Miramar- Site Number : 8400004Miramar, United StatesTaking people
- AMR Clinical South Strand, South Carolina- Site Number : 8400018Myrtle Beach, United StatesTaking people
- Icahn School of Medicine at Mount Sinai- Site Number : 8400021New York, United StatesTaking people
- Northridge Clinical Trials - Northridge- Site Number : 8400005Northridge, United StatesTaking people
- Medical Dermatology Specialists- Site Number : 8400019Phoenix, United StatesTaking people
- Georgia Skin & Cancer Clinic- Site Number : 8400009Savannah, United StatesTaking people
- Mayo Clinic in Arizona - Scottsdale- Site Number : 8400014Scottsdale, United StatesTaking people
- Washington University- Site Number : 8400010St Louis, United StatesTaking people
- The Iowa Clinic West Des Moines Campus- Site Number : 8400007West Des Moines, United StatesTaking people
About the trial
What the trial wants to find out
This is a Phase 2b, global, multicenter, sequential, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa.
Read full original descriptionShow less
The purpose of the main study is to assess the efficacy and safety of brivekimig in a dose-ranging study of participants with moderate to severe HS.
Study details include:
The study duration (per participant) will be up to approximately 164 weeks for participants transitioning into the long-term extension (LTE) period and will be up to approximately 60 weeks for participants not transitioning into the LTE period.
The randomized treatment duration will be up to approximately 152 weeks
The 4 groups in the trial
- Brivekimig dose regimen ATreatment being tested
Participants will receive Brivekimig dose regimen A.
Treatment: Brivekimig
- Brivekimig dose regimen BTreatment being tested
Participants will receive Brivekimig dose regimen B.
Treatment: Brivekimig
- Brivekimig dose regimen CTreatment being tested
Participants will receive Brivekimig dose regimen C.
Treatment: Brivekimig
- PlaceboPlacebo, for comparison
Participants will receive Brivekimig matching placebo.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study of Brivekimig Followed by a Maintenance Period in Participants With Moderate to Severe Hidradenitis Suppurativa
- Plain-language title
- Brivekimig compared with placebo for moderate to severe hidradenitis suppurativaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 14 October 2026